Wednesday, February 07, 2007

HPV Vaccine Concerns

First of all, I'd like to welcome new readers who have come here for information on the Texas HPV vaccine law. I hope you'll stick around. A few of you have made comments which have caused me to want to clarify my stance on the vaccine, as you have made very good points which I did not yet cover adequately. I have five main points of concern regarding the Merck vaccine and making it mandatory (even with opt out provisions):

1) Long-term effects data is not available
The vaccine in question has only been studied for a few years. This weekend I'll compile a list of citations for studies on the vaccine, and summarize some of the adverse effect data. However, none of this data will reflect whether girls will have problems with the vaccine further down the road.

2) Consumers do not have a choice
Another HPV vaccine made by another pharmaceutical company is currently being tested. If you're going to make the vaccine mandatory, why not wait until a second option is available and let patients make the choice?

3) HPV may not be an urgent or public health concern
Most other vaccines are for more readily transmittable infections, things you can catch through close contact or the air. HPV is not so readily transmissable. The "State" may not have as legitimate an interest in requiring this vaccine as it does in vaccines such as the MMR, so perhaps it should stay out of it.

4) Women do not have a choice.
The bodily autonomy argument is a difficult one. On one hand, the vaccine would be most effective if girls got it before they were sexually active, which for most people is going to mean while they are still minors and their parents are making medical decisions on their behalf. On the other hand, I'm not convinced that young girls should be forcefully subjected to something (by either parents or the State) for which long-term effects are not known.

5) The public is not receiving full disclosure of the interests of the legislators proposing these vaccine laws.
Several people have suggested that the Texas governor has financial ties to Merck. This should be something every parent is informed of. I did a search yesterday, and found the Merck political action committee had donated $5,000 to an organization supporting Perry's election. I don't want anyone's health messed around with for the sake of money.

There are aspects of the vaccine I support. I think it's a great idea when consumers have all available information. My own mother had cervical cancer, and her complaints were ignored by doctors until it was at a point where a hysterectomy was required. Growing up in the shadow of "I hope mom's cancer doesn't come back" tends to make you supportive of things that would prevent such cancers. Granted, cervical cancer is not the biggest killer of American women, but we don't have a vaccine for heart disease or breast cancer yet. I do think this vaccine is an encouraging development for researchers who may want to look for other viral causes of cancer (and some researchers are currently looking at viral causes of breast cancer in mice). I think it's a positive development, but that we may be jumping the gun when we start to require it. On the other hand, my understanding is that when the vaccines become mandatory, funds have to be allocated to provide the vaccine to people who could otherwise not afford this very expensive regimen, thus making protection available to more women. However, I think perhaps legislation could be passed to require funding without requiring vaccination for school entry.

It's a complicated issue, and I thank those of you who were civil and thoughtful in your comments and emails.

7 Comments:

Blogger saywhat said...

Rachel, Congratulations on being able to change your mind ... BTW: this vaccine would NOT have helped your mother at all... read why.

I have read Merck's clinical data on the vaccine, Gardasil:
From Merck's Clinical Studies:
http://www.merck.com/product/usa
/pi_circulars/g/gardasil
/gardasil_pi.pdf

1. Gardasil has NOT been evaluated for the potential to CAUSE carcinogenicity or genotoxicity.
(cancer or birth defects).

2.Merck's clinical data show, the vaccine is 0% effective in girls already exposed to 'any type' of HPV and was ONLY 100% effective for 36 months in girls who had never been exposed to HPV.

3. The mere fact that Merck's clinical data show that the vaccine is 0% effective for girls already exposed makes the "100% effective for 70% cervical cancer" claim medically untrue and impossible for the vaccine to achieve. Not to mention, Merck has no idea the percentage effectiveness beyond 36 months in girls who were never exposed.

4.thus, is it is mathematically impossible and clinical data do not support the vaccine to be 100% effective for 70% cervical cancers. In fact because you have to include the already infected girls who will be vaccinated in the overall percent effectiveness equation - the overall percent effectiveness is no where near 100%.

5. Gardasil does NOT protect against all types of HPV that cause cervical cancer.

6.The duration of immunity (length guarded against) following a complete schedule of immunization with Gardasil has not been established.

7. Women who became pregnant within 30 days or after 30 days of receiving Gardasil experienced "serious adverse experience during pregnancy.

8. Women who became pregnant within 30 days or after 30 days of receiving Gardasil experienced "serious adverse experience during pregnancy.

9. Serious adverse reactions" were found in infants whose mothers nursed them 30 days after receiving the vaccine. The "serious adverse reactions" were "acute respiratory illnesses.

This vaccine was NOT intended to prevent genetic cervical cancer.

It is a medical fact that 14 strains of HPV have been identified as high-risk for causing high grade cervical cell abnormalities that could lead to cervical cancer. The vaccine, Gardasil, "may help guard" against only 2 of the 14 strains. The 14 strains sexually transmitted, high-risk HPVs include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, and possibly a few others - source: National Cancer Institute.

From the CDC website: http://www.cdc.gov/std/hpv/

1. Vaccinated women will still be at risk for some cervical cancers.

2. The vaccine, Gardasil, does NOT protect against all types of HPV that cause cervical cancer.

3. More research is being done to find out how long protection will last, and if a booster vaccine is needed years later.


4. The vaccine has been studied in young women who had not been exposed to any of the four HPV types in the vaccine.

5. It will be important for women to continue getting screened for cervical cancer (regular Pap tests).

6. HPV infection can occur in both male and female genital areas.

7. In rare cases, genital HPV types can lead to development of cervical cancer.

8. The surest way to eliminate risk for genital HPV infection is to refrain from any genital contact with another individual.

9. Cervical cancer is an uncommon consequence of HPV infection in women, especially if they are screened for cancer regularly with Pap tests and have appropriate follow-up of abnormalities
In most women the HPV infection goes away on its own.

10. Most people who become infected with HPV will not have any symptoms and will clear the infection on their own.

11. Research has shown that for most women (90 percent), cervical HPV infection becomes undetectable within two years
Only a small proportion of women have persistent infection, persistent infection with "high-risk" types of HPV is the main risk factor for cervical cancer.

12. Regular Pap testing and careful medical follow-up, with treatment if necessary, can help ensure that pre-cancerous changes in the cervix caused by HPV infection do not develop into life threatening cervical cancer.

I think people are misreading and misinterpreting what the CDC website says, "Studies have found the vaccine to be almost 100% effective in preventing diseases .... The vaccine has mainly been studied in young women who had not been exposed to any of the four HPV types in the vaccine."

I think people are SKIPPING the word, "studies", not realizing it's "Merck's studies ONLY" and fixating on the 100% effective but NOT MAKING THE PARALLEL that the percentage effective ONLY comes from Merck's studies and only based off of girls that HAVE NOT BEEN EXPOSED to the HPV virus - which the CDC clearly states. As a result of people fixating and misreading that one statement - they are missing the true intent from the CDC. Thus, Physicians and non-physicians are making the false conclusion and saying in newspapers and in the news that, "this vaccine is 100% effective in 70% of cervical cancer" - Which is a statement NOT supported by Merck's clinical data, NOT what the CDC says and a mathematical impossibility because of the data.

My biggest concern is: If the most vulnerable group of young girls are mislead into thinking they don't need routine PAP screens if they get this vaccine - or mislead into thinking the vaccine "prevents" cervical cancer - or mislead into thinking they are 100% protected - a lot of cervical cancers will go undetected and the mortality rate will rise. It could be a future medical nightmare for our daughters generation if the most vulnerable group think they are protected from all HPV cervical cancer - when they are not - because they had this vaccine and therefore stopped getting routine PAP screens.

Oh well, Ya gotta love Merck's Marketing Strategy -- get it legislated MAKE TONS OF MONEY AND RECOVER ALL THE BILLIONS LOST IN THE VIOXX LAWSUITS.

10:47 AM  
Blogger MaryAnna said...

Great information. Glad to see that there are others out there opposing this draconian method of profit.

9:01 AM  
Blogger Malia said...

Hey, thanks for this post. It helped me clarify some things that I was pretty sure I understood about the vaccine but wasn't completely sure if I had all the right info. Did that make sense? Anyway...thanks!

2:21 PM  
Blogger Michelle said...

I am in debt to you and others for your excellent points and dialogue. It is not easy to not see the good in medical technology when it hits home. I know because I was part of a study for a new medication for children/teens with Myasthenia Gravis. We were warned that it was not a miracle drug and we would have to monitor the side effects VERY closely. My heart goes out to you Rachel! I hope that through education and dialogue we can make sure that "rash" governmental decisions aren't being made but ones to further women's health and public health in general are made. We must keep our minds open, educated and our chins up!

4:01 PM  
Anonymous jessica sobey said...

i was diagnosed with stage iv cervial cancer last November. In december I had a 15 minute procedure that was certainly uncomfortable but relatively mild on the pain scale. I strongly oppose the gardisil vaccine knowing all the information about merc's shady studies.. and the fact that cervical cancer has a huge nutrional component that hasn't even been mentioned by any of the maninstream disease mongorers. Defiecencies of folic acid, Vit A, Vit B6, Vit. C, selinium and Vit. E were found in almost all women with cervicall cancer. for various reasons even when intake of these vitamins were high absorption was low. There is also a huge difference with socioeconomic class and access to healthcare on who dies from cervical cancer and who survies. Subjecting generations of youg girls and woman to unknown risks to prevent a really manageable disease is negligable.

9:13 AM  
Blogger Rachel said...

Jessica,
Thank you for your comment. I hope you'll come on over to the new home of Women's Health News at http://womenshealthnews.wordpress.com.

9:14 AM  
Anonymous Sheila said...

Say what's # 2 above is incorrect. The vaccine is in- effective against only a strain already acquired, but not against the now 14 this vaccine blocks. As per cnn/health sept. 2007, in addition to the 4 most common, study confirms that 10 additional strains are blocked too, thus protecting against 90 % of hpv virus. The vaccine does not contain the more common ingredient giving allergic reactions, thimerasol a mercury deriviative. [see
http://www.fda.gov/cber/vaccine/thimerosal.htm & http://www.iom.edu/?ID=4705] It has very unfortunately caused Guillain-Barré syndrome as well as deaths from heart related problems and blood clots in rare instances. There are also many reports of other less serious and temporary adverse effects as of May 07'.
While cervical cancers or genital warts develop only rarely too from the overwhelming number of still infected preteens, teens & women, there is an epidemic and an estimated 3,700 deaths in America in 2006 will result from this 2nd world leader in female cancer death. While research is now concluding that these viruses, including wart strains can resolve and are not lifelong for most women, 3,700 lost lives are too many too and the seriousness of vertical transmission of respiratory papilomas as well as fetal death (miscarriage)now known to occur as a result of these infections, along with 100 % of metastatic breast cancer as shown in a recent Pub Med study and other cancers too, should cause another look and support of the HPV vaccines.
There will always be need for perfecting medical proceedures including these vaccinations, but the benefits of a vaccine that in an overwhelming majority of cases can change the course of young girls lives all over the world for a step towards the elimination of hpv virus once boys are vaccinated too, is a greater good for the entire world, not just for Americans whose health care affords surgeries if needed later for girls who do have sex but for the world over where medical care is hardly available to poorer families.
see discription: http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf

5:38 PM  

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